Replies to post #453754 on Anavex Life Sciences Corp (AVXL)

[frrol]

If the FDA assents to it (and indicates being receptive to an NDA), our 52 week OLE data, when we have it later this year, will be included in our NDA. It might not replace a confirmatory trial but rather just be considered additional safety data. (Its efficacy results would be considered supplemental.) We may also provide it to the EMA via the CHMP.

Looking forward to any new insights from tomorrow's PD/AD presentation. Not expecting any, but there's a chance.